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*It is only for medical professionals to read for reference.
There may be only one chance to choose PD-1, and you must seize the chance of long-term survival.
According to statistics from the World Health Organization, esophageal cancer is one of the top ten causes of death in the Chinese population in 2019; among all cancer deaths, it is second only to lung cancer, gastric cancer, and colorectal cancer, with a fatality rate of 16.
8 per 100,000.
World Health Organization statistics: The top ten causes of death in the Chinese population in 2019 [1] The high mortality rate of esophageal cancer stems from the lack of obvious early symptoms of esophageal cancer, so the disease has mostly developed to the locally advanced or inoperable metastatic stage at the first diagnosis ; Another problem of high fatality rate refraction is that there is still a lack of effective treatment for these patients, especially systemic treatment for inoperable locally advanced and advanced esophageal cancer patients with distant metastasis, whether it is first-line or second-line treatment , Has stagnated in the past few decades, and the median overall survival (OS) cannot exceed one year.
In 2020, the advent of the immunotherapy era will completely change the treatment "dilemma" for these patients.
The immunotherapy represented by the PD-1 immune checkpoint inhibitor pembrolizumab (commonly known as K drug in China) is first used in the second-line treatment of inoperable locally advanced and metastatic esophageal cancer.
KEYNOTE-181 clinical study of the Chinese subgroup data analysis results show that pembrolizumab in the second-line treatment of PD-L1 positive [comprehensive positive score (CPS) ≥ 10] inoperable locally advanced and metastatic esophageal cancer for 12 months The survival rate reached 53%, which was more than 3 times that of the chemotherapy group (16.
1%); the median OS reached 12.
0 months, which was 66% lower than the risk of death in the control group [2].KEYNOTE-181 Chinese subgroup OS data analysis results [2] Based on the results of the KEYNOTE-181 study, in June 2020, the National Medical Products Administration (NMPA) of my country approved K drugs for PD-L1 CPS ≥ 10, the previous first-line Treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed systemic therapy.
Immediately afterwards, the 2020 European Society of Medical Oncology (ESMO) conference announced a phase III clinical study of pembrolizumab combined with chemotherapy (cisplatin + 5-fluorouracil) for the first-line treatment of inoperable locally advanced or metastatic esophageal cancer The results of the KEYNOTE-590 study showed for the first time that regardless of the expression of PD-L1, the first-line immune combined chemotherapy regimen can significantly improve OS compared with standard chemotherapy regimens.
The overall population median OS is 12.
4 months (9.
8 months of chemotherapy), PD-L1 The median OS of the esophageal squamous cell carcinoma population with CPS ≥ 10 was 5.
1 months longer than that in the chemotherapy group (13.
9 months vs 8.
8 months) [3].
Immediately afterwards, the domestic market application of pembrolizumab combined with chemotherapy for the first-line treatment of inoperable locally advanced or metastatic esophageal cancer indications was submitted to the NMPA in November 2020 and is expected to be approved in 2021.
Click to watch the wonderful video of Professor Xu Jianming.
Why is 2020 called the first year of immunotherapy for esophageal cancer in China? Professor Xu Jianming: 2020 is a year of major breakthroughs in the treatment of esophageal cancer.
In the past few decades, there have been few breakthroughs in the treatment of advanced esophageal squamous cell carcinoma.
Apart from chemotherapy, there are no other options and no new drugs have been approved.
However, between 2019 and 2020, pembrolizumab and nivoliuzumab, two PD-1 immune checkpoint inhibitors, were approved internationally for the second-line treatment of advanced esophageal cancer.
China also approved pembrolizumab in 2020.
And Carrelizumab as a second-line treatment for advanced esophageal cancer. The results of the phase III clinical studies of these PD-1 monoclonal antibodies all show that PD-1 monoclonal antibody brings significant OS improvement compared with chemotherapy, especially the phase III clinical study of KEYNOTE-181 with a large sample size is the first to show that the Among Chinese patients with esophageal squamous cell carcinoma with CPS ≥ 10, the effective rate of K-drug monotherapy is 25%, which is more than 3 times higher than that of chemotherapy, and the median OS is also significantly prolonged.
Therefore, KEYNOTE-181 has brought a historic breakthrough in the treatment of esophageal cancer globally and in China.
How does the immunotherapy of esophageal cancer screen the dominant population? Professor Xu Jianming: Judging from the results of several large-scale phase III clinical studies including KEYNOTE-181 in the world, among patients with PD-L1 CPS ≥ 10, the OS benefit brought by drug K monotherapy is Significantly better than the overall population, which means that whether it is esophageal squamous cell carcinoma or adenocarcinoma, PD-L1 CPS should be a better biomarker.
However, the ESCORT study for Chinese esophageal squamous cell carcinoma and the ATTRACTION-3 study for Asian esophageal squamous cell carcinoma used the PD-L1 TPS detection method, but the results showed that PD-L1 TPS was used to screen patients, PD-L1 expression positive and negative patients There is a difference in survival time, but this difference is not significant.
Therefore, PD-L1 CPS is a better indicator to screen the dominant population of immunotherapy, rather than PD-L1 TPS, and PD-L1 should use CPS ≥ 10 as a threshold.
The KEYNOTE-181 study confirmed the benefits of this population, and the same results were obtained in the study of the Chinese population: life benefits are better, and the objective remission rate is higher.
How long does it take to receive K drug treatment? If the patient does not achieve PR or CR in the first four courses of treatment, should the treatment be continued? Professor Xu Jianming: The anti-tumor efficacy of K drug often appears in the third (9 weeks) to the fourth cycle (12 weeks) of its treatment.
Once it is effective, the median time of remission exceeds 6 months, and can even exceed one.
year.
During this period of partial tumor remission (PR) or complete remission (CR), patients' confidence in treatment and quality of life will be greatly improved.
After receiving 4 courses of K drug treatment, even if there is no CR or PR, if you receive 2 more treatment courses and receive follow-up (29 courses) charity assistance, the possibility of continuing to benefit will still be relatively high.
The charity patient assistance project is a very good gospel for our Chinese patients with esophageal cancer, because K drug treatment of esophageal squamous cell carcinoma is better than adenocarcinoma, and 90% of esophageal cancer in China is esophageal squamous cell carcinoma, so Chinese patients will benefit very large.
The patient assistance program can make K medicine affordable to more patients in the initial stage.
There may be only one chance to choose PD-1, and the right choice can seize the chance of long-term survival.
Because different manufacturers produce PD-1 monoclonal antibodies, both in terms of efficacy and safety, are different.
Win at the starting line to extend the lifeline! Expert Profile Prof.
Jianming Xu, Director of the Department of Gastroenterology and Oncology, Fifth Medical Center, PLA General Hospital, Professor, PhD supervisor, Vice Chairman, Big Data and Real World Professional Committee, China Anti-Cancer Association, Vice Chairman, Chinese Research Hospital Oncology Committee, Chinese Society of Clinical Oncology References for the Chairman of the Gastrointestinal Pancreatic Neuroendocrine Tumor Professional Committee: [1]WHO, https:// causes-of-death[2]Chen J et al.
, Pembrolizumab versus Chemotherapy in Patients with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus as Second-line Therapy: Analysis of the Chinese Sub-group in KEYNOTE-181, Abstract , 2019 ESMO[3]Ken Kato et al.
, Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients with Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study, ESMO 2020, LBA 8
There may be only one chance to choose PD-1, and you must seize the chance of long-term survival.
According to statistics from the World Health Organization, esophageal cancer is one of the top ten causes of death in the Chinese population in 2019; among all cancer deaths, it is second only to lung cancer, gastric cancer, and colorectal cancer, with a fatality rate of 16.
8 per 100,000.
World Health Organization statistics: The top ten causes of death in the Chinese population in 2019 [1] The high mortality rate of esophageal cancer stems from the lack of obvious early symptoms of esophageal cancer, so the disease has mostly developed to the locally advanced or inoperable metastatic stage at the first diagnosis ; Another problem of high fatality rate refraction is that there is still a lack of effective treatment for these patients, especially systemic treatment for inoperable locally advanced and advanced esophageal cancer patients with distant metastasis, whether it is first-line or second-line treatment , Has stagnated in the past few decades, and the median overall survival (OS) cannot exceed one year.
In 2020, the advent of the immunotherapy era will completely change the treatment "dilemma" for these patients.
The immunotherapy represented by the PD-1 immune checkpoint inhibitor pembrolizumab (commonly known as K drug in China) is first used in the second-line treatment of inoperable locally advanced and metastatic esophageal cancer.
KEYNOTE-181 clinical study of the Chinese subgroup data analysis results show that pembrolizumab in the second-line treatment of PD-L1 positive [comprehensive positive score (CPS) ≥ 10] inoperable locally advanced and metastatic esophageal cancer for 12 months The survival rate reached 53%, which was more than 3 times that of the chemotherapy group (16.
1%); the median OS reached 12.
0 months, which was 66% lower than the risk of death in the control group [2].KEYNOTE-181 Chinese subgroup OS data analysis results [2] Based on the results of the KEYNOTE-181 study, in June 2020, the National Medical Products Administration (NMPA) of my country approved K drugs for PD-L1 CPS ≥ 10, the previous first-line Treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) who have failed systemic therapy.
Immediately afterwards, the 2020 European Society of Medical Oncology (ESMO) conference announced a phase III clinical study of pembrolizumab combined with chemotherapy (cisplatin + 5-fluorouracil) for the first-line treatment of inoperable locally advanced or metastatic esophageal cancer The results of the KEYNOTE-590 study showed for the first time that regardless of the expression of PD-L1, the first-line immune combined chemotherapy regimen can significantly improve OS compared with standard chemotherapy regimens.
The overall population median OS is 12.
4 months (9.
8 months of chemotherapy), PD-L1 The median OS of the esophageal squamous cell carcinoma population with CPS ≥ 10 was 5.
1 months longer than that in the chemotherapy group (13.
9 months vs 8.
8 months) [3].
Immediately afterwards, the domestic market application of pembrolizumab combined with chemotherapy for the first-line treatment of inoperable locally advanced or metastatic esophageal cancer indications was submitted to the NMPA in November 2020 and is expected to be approved in 2021.
Click to watch the wonderful video of Professor Xu Jianming.
Why is 2020 called the first year of immunotherapy for esophageal cancer in China? Professor Xu Jianming: 2020 is a year of major breakthroughs in the treatment of esophageal cancer.
In the past few decades, there have been few breakthroughs in the treatment of advanced esophageal squamous cell carcinoma.
Apart from chemotherapy, there are no other options and no new drugs have been approved.
However, between 2019 and 2020, pembrolizumab and nivoliuzumab, two PD-1 immune checkpoint inhibitors, were approved internationally for the second-line treatment of advanced esophageal cancer.
China also approved pembrolizumab in 2020.
And Carrelizumab as a second-line treatment for advanced esophageal cancer. The results of the phase III clinical studies of these PD-1 monoclonal antibodies all show that PD-1 monoclonal antibody brings significant OS improvement compared with chemotherapy, especially the phase III clinical study of KEYNOTE-181 with a large sample size is the first to show that the Among Chinese patients with esophageal squamous cell carcinoma with CPS ≥ 10, the effective rate of K-drug monotherapy is 25%, which is more than 3 times higher than that of chemotherapy, and the median OS is also significantly prolonged.
Therefore, KEYNOTE-181 has brought a historic breakthrough in the treatment of esophageal cancer globally and in China.
How does the immunotherapy of esophageal cancer screen the dominant population? Professor Xu Jianming: Judging from the results of several large-scale phase III clinical studies including KEYNOTE-181 in the world, among patients with PD-L1 CPS ≥ 10, the OS benefit brought by drug K monotherapy is Significantly better than the overall population, which means that whether it is esophageal squamous cell carcinoma or adenocarcinoma, PD-L1 CPS should be a better biomarker.
However, the ESCORT study for Chinese esophageal squamous cell carcinoma and the ATTRACTION-3 study for Asian esophageal squamous cell carcinoma used the PD-L1 TPS detection method, but the results showed that PD-L1 TPS was used to screen patients, PD-L1 expression positive and negative patients There is a difference in survival time, but this difference is not significant.
Therefore, PD-L1 CPS is a better indicator to screen the dominant population of immunotherapy, rather than PD-L1 TPS, and PD-L1 should use CPS ≥ 10 as a threshold.
The KEYNOTE-181 study confirmed the benefits of this population, and the same results were obtained in the study of the Chinese population: life benefits are better, and the objective remission rate is higher.
How long does it take to receive K drug treatment? If the patient does not achieve PR or CR in the first four courses of treatment, should the treatment be continued? Professor Xu Jianming: The anti-tumor efficacy of K drug often appears in the third (9 weeks) to the fourth cycle (12 weeks) of its treatment.
Once it is effective, the median time of remission exceeds 6 months, and can even exceed one.
year.
During this period of partial tumor remission (PR) or complete remission (CR), patients' confidence in treatment and quality of life will be greatly improved.
After receiving 4 courses of K drug treatment, even if there is no CR or PR, if you receive 2 more treatment courses and receive follow-up (29 courses) charity assistance, the possibility of continuing to benefit will still be relatively high.
The charity patient assistance project is a very good gospel for our Chinese patients with esophageal cancer, because K drug treatment of esophageal squamous cell carcinoma is better than adenocarcinoma, and 90% of esophageal cancer in China is esophageal squamous cell carcinoma, so Chinese patients will benefit very large.
The patient assistance program can make K medicine affordable to more patients in the initial stage.
There may be only one chance to choose PD-1, and the right choice can seize the chance of long-term survival.
Because different manufacturers produce PD-1 monoclonal antibodies, both in terms of efficacy and safety, are different.
Win at the starting line to extend the lifeline! Expert Profile Prof.
Jianming Xu, Director of the Department of Gastroenterology and Oncology, Fifth Medical Center, PLA General Hospital, Professor, PhD supervisor, Vice Chairman, Big Data and Real World Professional Committee, China Anti-Cancer Association, Vice Chairman, Chinese Research Hospital Oncology Committee, Chinese Society of Clinical Oncology References for the Chairman of the Gastrointestinal Pancreatic Neuroendocrine Tumor Professional Committee: [1]WHO, https:// causes-of-death[2]Chen J et al.
, Pembrolizumab versus Chemotherapy in Patients with Advanced/Metastatic Adenocarcinoma or Squamous Cell Carcinoma of the Esophagus as Second-line Therapy: Analysis of the Chinese Sub-group in KEYNOTE-181, Abstract , 2019 ESMO[3]Ken Kato et al.
, Pembrolizumab Plus Chemotherapy Versus Chemotherapy as First-Line Therapy in Patients with Advanced Esophageal Cancer: The Phase 3 KEYNOTE-590 Study, ESMO 2020, LBA 8
